Influence of Positive Margins on Tumour Recurrence and Ov... | NCT04439812

Studies
Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer

NCT04439812

Sponsor

Hospital Universitario Ramon y Cajal

Status

Completed

Last Update Posted

Jun 19, 2020Actual

Enrollment

267Actual

Phase

Not provided

Conditions

Stomach Neoplasms

Interventions

Observation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 17, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2020

Last Update Posted Date

Jun 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pablo Priego, Consultant surgeon MD, PhD. Associate Profesor of Surgery, Hospital Universitario Ramon y CajalPrincipal Investigator

Lead Sponsor

Hospital Universitario Ramon y CajalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

267Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
R=0		Patients without positive margins after gastrectomy for gastric cancer	Other: Observation
R=1		Patients with positive margins after gastrectomy for gastric cancer	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC		8 years

Secondary Outcomes

Measure	Description	Time Frame
The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.		8 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.

Exclusion Criteria:

distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. Resections in patients with palliative intent were also excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pablo Priego, MD, PhD	Hospital Universitario Ramón y Cajal	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D000072662	Margins of Excision
D012008	Recurrence

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided